|
Device | ARCTIC FRONT CRYOCATHETER SYSTEM |
Generic Name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MS MVS46 MOUNDS VIEW, MN 55112 |
PMA Number | P100010 |
Supplement Number | S053 |
Date Received | 02/10/2016 |
Decision Date | 03/11/2016 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of a new part number and component specifications for an internal USB memory drive to address field reports related to inadequate USB drive performance. |